My Rheumatology highlights from 2016
As we start the new year 2017, here are my rheumatology highlights from papers and abstracts in 2016. These were papers and abstracts in no particular order. I discussed these papers with colleagues at conferences, meetings and journal clubs. I hope you find them useful.
They were many other papers but due to space and time, I have not included all of them here.
Do share your favourite rheumatology papers from 2016 too.
Baricitinib in Patients with Refractory Rheumatoid
Arthritis.
N Engl J Med. 2016 Mar 31;374(13):1243-52
Genovese MC
et al
Phase 3 study involving 527 patients with an inadequate
response to or unacceptable side effects associated with one or more tumor
necrosis factor inhibitors, other biologic DMARDs, or both, we randomly
assigned the patients in a 1:1:1 ratio to baricitinib at
a dose of 2 or 4 mg daily or placebo for 24 weeks. Significantly more patients
receiving baricitinib at the 4 -mg dose than those receiving
placebo had an ACR20 response at week 12 (55% vs. 27%, P<0.001). In patients
with rheumatoid
arthritis and an
inadequate response to biologic DMARDs, baricitinib at
a daily dose of 4 mg was associated with clinical improvement at 12 weeks.
Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe
systemic lupus erythematosus: a randomised, double-blind, placebo-controlled
study.
Khamashta M
et al
Ann Rheum Dis. 2016 Nov;75(11):1909-1916.
The efficacy and safety of sifalimumab were assessed in a phase IIb,
randomised, double-blind, placebo-controlled studyof adults with moderate to
severe active systemic lupus erythematosus (SLE). Compared
with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end
point of SLE responder
index response at week 52 (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%;
1200 mg 59.8%). Sifalimumab is a promising treatment for adults
with SLE.
Improvement was consistent across various clinical end points, including global
and organ-specific measures of disease activity.
Efficacy and Safety of Switching Between Certolizumab Pegol and
Adalimumab after Primary Anti-TNF Treatment Failure: 2-Year Results from a
Randomized, Investigator-Blind, Superiority Head-to-Head Study
ACR ABSTRACT NUMBER: 602
Fleischmann
R et al
EXXELERATE is the first
randomized controlled trial (RCT) to address immediate switching to another TNFi,
in a TNFi IR patient population. EXXELERATE was a 104-wk randomized,
investigator-blind, parallel-group, head-to-head superiority study comparing the
early (Wk 12)- and Wk 104 efficacy and safety of certolizumab pegol (CZP)+MTX vs
adalimumab (ADA)+MTX. Pts were randomized 1:1 to CZP+MTX or ADA+MTX. Clinical improvement was
observed in a considerable proportion of pts; 33 pts (55.9%) switching to CZP
and 40 pts (60.6%) switching to ADA responded 12 wks later (Wk 24) by achieving
DAS28(ESR) ≤3.2 or a DAS28(ESR) reduction from Wk 12 of ≥1.2. EXXELERATE demonstrated that
efficacy can be achieved using a second TNFi in a proven primary TNFi failure
pt population.
Tapering biologic and conventional DMARD therapy
in rheumatoid arthritis: current evidence and future directions.
Ann Rheum Dis. 2016
Aug;75(8):1428-37
Schett G
et al
This
review article discusses the current developments of DMARD tapering and provides
an overview of existing studies on this topic and addresses new strategies to
reach drug-free remission. Defining patients eligible for DMARD tapering are
described and potential future strategies in using biomarkers in predicting the
risk for disease relapse after initiation of DMARD tapering are addressed.
Efficacy and Safety of Tocilizumab in Patients with Giant Cell
Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized,
Double-Blind, Placebo-Controlled Trial
ACR 2016 ABSTRACT NUMBER: 911
Stone JH et al
The early results of GiACTA study confirm the efficacy of
tocilizumab (TCZ) in giant cell arteritis. TCZ with a
26-week prednisone taper was superior to both short- and long-course prednisone
tapers for the achievement of sustained remission at 52 weeks. The addition of
TCZ to prednisone also led to a substantial reduction in the cumulative
prednisone doses required to control GCA.
Combination Therapy of Apremilast and Biologic Agent As a Safe
Option of Psoriatic Arthritis and Psoriasis
ACR ABSTRACT NUMBER: 1725
Metyas et al
Apremilast can be safely and effectively combined with biologic
agents in patients with plaque psoriasis or psoriatic arthritis not responding
adequately to these agents alone. No major side effects of cancer or sever
infection were reported other than nausea and/or vomiting that were manageable
in some patients.
No Increased Risk of Inflammatory Bowel Disease Among
Secukinumab-Treated Patients with Moderate to Severe Psoriasis, Psoriatic
Arthritis, or Ankylosing Spondylitis: Data from 14 Phase 2 and Phase 3 Clinical
Studies
ACR ABSTRACT NUMBER: 962
Deodhar
A et al
Events of CD and UC in the 14 clinical studies were reported
infrequently in secukinumab-treated pts with psoriasis, PsA, or AS; rates were
similar across the psoriasis and PsA cohorts. EAIR rates of CD and UC
observed in secukinumab-treated pts are consistent with those reported in the
literature in psoriasis, PsA, and AS populations.
A Single Infusion of Rituximab Delays the Onset of Arthritis in
Subjects at High Risk of Developing RA
ACR 2016 ABSTRACT
NUMBER: 3028
The PRAIRI study
reporting preliminary data from a randomized, blinded study of 81 participants.
When given to individuals with preclinical RA (elevated antibodies to
citrullinated proteins and rheumatoid factor but no synovitis on baseline
examination), a single infusion of 1000 mg rituximab significantly delays
the development of arthritis in subjects at risk of developing RA by
about 12 months.
Cardiovascular Safety of Celecoxib, Naproxen, or
Ibuprofen for Arthritis
N Engl J Med. 2016 Dec 29;375(26):2519-29
Nissen SE et al
The
cardiovascular safety of celecoxib was compared with nonselective nonsteroidal antiinflammatory
drugs (NSAIDs). At moderate doses, celecoxib was found to be noninferior to
ibuprofen or naproxen with regard to cardiovascular safety.
Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease.
N Engl J Med. 2016 Nov 17;375(20):1946-1960
Feagan BG
et al.
Patients received a single
intravenous dose of ustekinumab (either
130 mg or approximately 6 mg per kilogram of body weight) or placebo in two
induction trials. The UNITI-1 trial included 741 patients who met the criteria
for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists
or had unacceptable side effects. The UNITI-2 trial included 628 patients in
whom conventional therapy failed or unacceptable side effects occurred.
Patients who completed these induction trials then participated in IM-UNITI, in
which the 397 patients who had a response to ustekinumab were
randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks)
or placebo. Patients with moderately to severely active Crohn's disease,
those receiving intravenous ustekinumab had
a significantly higher rate of response than did those receiving placebo.
Subcutaneous ustekinumab maintained
remission in patients who had a clinical response to induction therapy.
Tumour necrosis factor inhibition versus rituximab for
patients with rheumatoid arthritis who require biological treatment (ORBIT): an
open-label, randomised controlled, non-inferiority, trial
Lancet. 2016; 388: 239-247
Porter D et al
Data from
the Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic
Therapy (ORBIT) study showed that initial
treatment with rituximab is non-inferior to initial TNF inhibitor treatment in
patients seropositive for rheumatoid arthritis and naive to treatment with
biologicals, and is cost saving over 12 months.
